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A comparison of methods for constructing confidence intervals after phase II/III clinical trials
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Kimani, Peter K., Todd, Susan and Stallard, Nigel (2014) A comparison of methods for constructing confidence intervals after phase II/III clinical trials. Biometrical Journal, Volume 56 (Number 1). pp. 107-128. doi:10.1002/bimj.201300036 ISSN 0323-3847.
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Official URL: http://dx.doi.org/10.1002/bimj.201300036
Abstract
Recently, in order to accelerate drug development, trials that use adaptive seamless designs such as phase II/III clinical trials have been proposed. Phase II/III clinical trials combine traditional phases II and III into a single trial that is conducted in two stages. Using stage 1 data, an interim analysis is performed to answer phase II objectives and after collection of stage 2 data, a final confirmatory analysis is performed to answer phase III objectives. In this paper we consider phase II/III clinical trials in which, at stage 1, several experimental treatments are compared to a control and the apparently most effective experimental treatment is selected to continue to stage 2. Although these trials are attractive because the confirmatory analysis includes phase II data from stage 1, the inference methods used for trials that compare a single experimental treatment to a control and do not have an interim analysis are no longer appropriate. Several methods for analysing phase II/III clinical trials have been developed. These methods are recent and so there is little literature on extensive comparisons of their characteristics. In this paper we review and compare the various methods available for constructing confidence intervals after phase II/III clinical trials.
Item Type: | Journal Article | ||||||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | Biometrical Journal | ||||||||||
Publisher: | Wiley - V C H Verlag GmbH & Co. KGaA | ||||||||||
ISSN: | 0323-3847 | ||||||||||
Official Date: | 2 January 2014 | ||||||||||
Dates: |
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Volume: | Volume 56 | ||||||||||
Number: | Number 1 | ||||||||||
Page Range: | pp. 107-128 | ||||||||||
DOI: | 10.1002/bimj.201300036 | ||||||||||
Status: | Peer Reviewed | ||||||||||
Publication Status: | Published | ||||||||||
Access rights to Published version: | Restricted or Subscription Access |
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